NCT06625307

A Research Study on the Effects of NNC0537-1482 in Healthy Individuals When Injected Under the Skin

A First-in-human Randomised, Placebo-controlled and Double-blinded Single Ascending Dose Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administrations of NNC0537-1482 in Healthy Participants.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 22 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The study is testing a new medicine to potentially treat people with heart failure. The main purpose of the study is to see if the new study medicine is safe and how it works in the body. It is the first time NNC0537-1482 (the new study medicine) is tested in humans and will be tested in healthy individuals (men and postmenopausal women). Participant will either get NNC0537-1482 or placebo (a "dummy medicine" without any active ingredients). Which treatment the participant get is decided by chance and the participant will only get either the study medicine or placebo on one occasion. It will be injected under the skin of the stomach by the study staff and the number of injections will depend on the cohort participant is assigned to. NNC0537-1482 cannot be prescribed by doctors. The study consists of 6 cohorts (groups) with 6 different dosing levels. The study will last for about 9 months. Participation in the study will last up to 42 days (depending on the cohort participant are assigned to) with an additional screening period that can be up to 28 days. Participant will have up to 10 visits to the clinic during the study period. However, the total number of visits depend on which cohort participant is assigned to.

Conditions

• Healthy Volunteers
• Heart Failure

Interventions

Type	Name	Description
DRUG	NNC0537-1482	Administered via subcutaneous route
DRUG	Placebo	Administered via subcutaneous route

Timeline

• Start date: 2024-10-03
• Primary completion: 2025-05-04
• Completion: 2025-05-04
• First posted: 2024-10-03
• Last updated: 2025-06-25

Locations

1 site across 1 country: Netherlands